EP3733717A3 - Verbessertes verfahren zur herstellung von sugammadex - Google Patents

Verbessertes verfahren zur herstellung von sugammadex Download PDF

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Publication number
EP3733717A3
EP3733717A3 EP20175964.4A EP20175964A EP3733717A3 EP 3733717 A3 EP3733717 A3 EP 3733717A3 EP 20175964 A EP20175964 A EP 20175964A EP 3733717 A3 EP3733717 A3 EP 3733717A3
Authority
EP
European Patent Office
Prior art keywords
sugammadex
preparation
improved process
propionic acid
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20175964.4A
Other languages
English (en)
French (fr)
Other versions
EP3733717A2 (de
Inventor
Walter Cabri
Antonio Ricci
Jacopo Zanon
Saswata Lahiri
Govind Singh
Shivaji Haribhau Shelke
Tapanjyoti BISWAL
Nitin Kumar
Madan Singh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Ipsum SRL
Original Assignee
Fresenius Kabi Ipsum SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Ipsum SRL filed Critical Fresenius Kabi Ipsum SRL
Publication of EP3733717A2 publication Critical patent/EP3733717A2/de
Publication of EP3733717A3 publication Critical patent/EP3733717A3/de
Withdrawn legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C319/00—Preparation of thiols, sulfides, hydropolysulfides or polysulfides
    • C07C319/02—Preparation of thiols, sulfides, hydropolysulfides or polysulfides of thiols
    • C07C319/12—Preparation of thiols, sulfides, hydropolysulfides or polysulfides of thiols by reactions not involving the formation of mercapto groups
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C323/00—Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups
    • C07C323/50—Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton
    • C07C323/51—Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C323/52—Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003—General processes for their isolation or fractionation, e.g. purification or extraction from biomass

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Materials Engineering (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • General Health & Medical Sciences (AREA)
  • Sustainable Development (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
EP20175964.4A 2016-03-22 2017-03-20 Verbessertes verfahren zur herstellung von sugammadex Withdrawn EP3733717A3 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201611009993 2016-03-22
PCT/IB2017/051594 WO2017163165A1 (en) 2016-03-22 2017-03-20 An improved process for the preparation of sugammadex
EP17720572.1A EP3433285B1 (de) 2016-03-22 2017-03-20 Ein verbesserter prozess zur herstellung von sugammadex

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP17720572.1A Division EP3433285B1 (de) 2016-03-22 2017-03-20 Ein verbesserter prozess zur herstellung von sugammadex

Publications (2)

Publication Number Publication Date
EP3733717A2 EP3733717A2 (de) 2020-11-04
EP3733717A3 true EP3733717A3 (de) 2020-12-30

Family

ID=58645335

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20175964.4A Withdrawn EP3733717A3 (de) 2016-03-22 2017-03-20 Verbessertes verfahren zur herstellung von sugammadex
EP17720572.1A Active EP3433285B1 (de) 2016-03-22 2017-03-20 Ein verbesserter prozess zur herstellung von sugammadex

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP17720572.1A Active EP3433285B1 (de) 2016-03-22 2017-03-20 Ein verbesserter prozess zur herstellung von sugammadex

Country Status (9)

Country Link
US (1) US10577433B2 (de)
EP (2) EP3733717A3 (de)
JP (1) JP6829304B2 (de)
KR (1) KR20180127428A (de)
CN (1) CN108779186B (de)
AU (1) AU2017236669B2 (de)
ES (1) ES2810980T3 (de)
SI (1) SI3433285T1 (de)
WO (1) WO2017163165A1 (de)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10414830B2 (en) 2015-11-25 2019-09-17 Fresenius Kabi Ipsum S.R.L. Crystalline forms of per-chloro-γ-cyclodextrines
WO2017089966A1 (en) 2015-11-25 2017-06-01 Fresenius Kabi Antiinfectives S.R.L. An improved process for the preparation of sugammadex and its intermediates
ES2915423T3 (es) 2016-06-23 2022-06-22 Synthon Bv Proceso de preparación de sugammadex
US10385142B2 (en) * 2017-01-23 2019-08-20 Scinopharm Taiwan, Ltd. Method for preparing sugammadex sodium
US10336835B2 (en) * 2017-08-23 2019-07-02 Formosa Laboratories, Inc. Polymorphs of sugammadex and process for preparation of sugammadex
ES2948930T3 (es) 2017-11-27 2023-09-21 Medichem Sa Proceso para la síntesis de un derivado de ciclodextrina
CN107892727B (zh) * 2017-11-27 2019-12-24 合肥博思科创医药科技有限公司 一种舒更葡糖钠的纯化方法
EP3775026B1 (de) 2018-04-06 2022-03-16 Synthon B.V. Aufreinigung von sugammadex
BR112020024822B1 (pt) 2018-06-07 2024-03-12 Merck Sharp & Dohme Llc Processos para a preparação de sugammadex
CN110655594B (zh) * 2018-06-29 2021-04-30 江苏海悦康医药科技有限公司 一种单羟基舒更葡糖钠的制备方法
WO2020013759A1 (en) * 2018-07-12 2020-01-16 Scinopharm Taiwan Ltd. Method for preparing sugammadex sodium
CN109053933B (zh) * 2018-08-01 2020-10-23 合肥博思科创医药科技有限公司 一种无定型舒更葡糖钠的制备方法
US11845811B2 (en) 2018-09-20 2023-12-19 Natco Pharma Limited Process for the preparation of Sugammadex sodium and its novel polymorphic form
CN112752770A (zh) * 2018-09-27 2021-05-04 韦尔滕施泰因生物制药公司 舒更葡糖的新型晶体形式
CN109593143B (zh) * 2018-12-29 2021-02-09 博瑞生物医药（苏州）股份有限公司 一种舒更葡糖钠制备中间体的纯化方法
CN109824800A (zh) * 2018-12-29 2019-05-31 鼎元(天津)生物医药科技有限公司 一种选择性肌松拮抗药舒更葡萄糖钠的制备方法
EP3753946A1 (de) 2019-06-18 2020-12-23 Fresenius Kabi iPSUM S.r.l. Verbessertes verfahren zur herstellung von hochreinem glucagon
US11324692B2 (en) 2019-07-03 2022-05-10 Galenicum Health S.L.U. Method to prepare pharmaceutical compositions of suggamadex
JP2023515087A (ja) 2020-02-28 2023-04-12 メディチェム エセ．ア． スガマデクスを乾燥させるための方法
CN113456598B (zh) * 2020-03-31 2024-04-02 鲁南制药集团股份有限公司 一种舒更葡糖钠冻干粉针剂及其制备方法
US11097023B1 (en) 2020-07-02 2021-08-24 Par Pharmaceutical, Inc. Pre-filled syringe containing sugammadex
ES2949710T1 (es) 2020-07-03 2023-10-02 Galenicum Health S L U Método para preparar composiciones farmacéuticas
WO2022055916A1 (en) * 2020-09-09 2022-03-17 Merck Sharp & Dohme Corp. Process for preparing sugammadex
CN112279938A (zh) * 2020-10-26 2021-01-29 江苏阿尔法药业有限公司 一种舒更葡糖钠药物中间体的制备方法
CN115266968B (zh) * 2022-03-30 2024-07-16 上海上药创新医药技术有限公司 一种hplc分离测定舒更葡糖钠中间体及其杂质的方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001040316A1 (en) * 1999-11-29 2001-06-07 Akzo Nobel N.V. 6-mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block
WO2012025937A1 (en) * 2010-08-25 2012-03-01 Ramamohan Rao Davuluri Improved process for preparation of sugammadex
WO2014125501A1 (en) * 2013-02-14 2014-08-21 Neuland Laboratories Limited An improved process for preparation of sugammadex sodium
CN105273095A (zh) * 2014-05-28 2016-01-27 四川海思科制药有限公司 一种舒更葡糖钠及其中间体的制备方法
WO2016194001A1 (en) * 2015-05-29 2016-12-08 Alaparthi Lakshmi Prasad Processes for preparation of sugammadex and intermediates thereof
WO2017089966A1 (en) * 2015-11-25 2017-06-01 Fresenius Kabi Antiinfectives S.R.L. An improved process for the preparation of sugammadex and its intermediates

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101864003B (zh) 2010-06-11 2012-05-02 漆又毛 一种6-脱氧硫醚氨基酸环糊精衍生物的合成方法
CN104844732B (zh) 2015-03-27 2017-05-03 山东滨州智源生物科技有限公司 一种舒更葡糖钠的制备方法
CN106749771A (zh) * 2015-11-23 2017-05-31 成都渊源生物科技有限公司 一种高纯度的舒更葡糖钠制备方法
US10414830B2 (en) 2015-11-25 2019-09-17 Fresenius Kabi Ipsum S.R.L. Crystalline forms of per-chloro-γ-cyclodextrines

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001040316A1 (en) * 1999-11-29 2001-06-07 Akzo Nobel N.V. 6-mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block
WO2012025937A1 (en) * 2010-08-25 2012-03-01 Ramamohan Rao Davuluri Improved process for preparation of sugammadex
WO2014125501A1 (en) * 2013-02-14 2014-08-21 Neuland Laboratories Limited An improved process for preparation of sugammadex sodium
CN105273095A (zh) * 2014-05-28 2016-01-27 四川海思科制药有限公司 一种舒更葡糖钠及其中间体的制备方法
WO2016194001A1 (en) * 2015-05-29 2016-12-08 Alaparthi Lakshmi Prasad Processes for preparation of sugammadex and intermediates thereof
WO2017089966A1 (en) * 2015-11-25 2017-06-01 Fresenius Kabi Antiinfectives S.R.L. An improved process for the preparation of sugammadex and its intermediates

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GIAN TOMASO MASALA: "3rd party observation", PROCEEDINGS OF EARLIER APPLCATION, 19 March 2019 (2019-03-19), EPO, XP055723193 *

Also Published As

Publication number Publication date
AU2017236669B2 (en) 2021-02-18
EP3433285B1 (de) 2020-06-03
EP3433285A1 (de) 2019-01-30
JP2019510128A (ja) 2019-04-11
WO2017163165A1 (en) 2017-09-28
US10577433B2 (en) 2020-03-03
CN108779186B (zh) 2021-07-13
US20190284308A1 (en) 2019-09-19
ES2810980T3 (es) 2021-03-10
AU2017236669A1 (en) 2018-09-27
JP6829304B2 (ja) 2021-02-10
CN108779186A (zh) 2018-11-09
KR20180127428A (ko) 2018-11-28
EP3733717A2 (de) 2020-11-04
SI3433285T1 (sl) 2020-10-30

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